Pharma Regulatory Affairs (12 Months)

The total revolution of biological and chemical sciences has resulted into new concepts in pharmaceutical sciences giving rise to importance of regulations for the new products. The pharma regulatory affairs are important for the knowledge of the laws and regulations mandated by the federal government, especially those of the Food and Drug Administration (FDA), as they apply to the development, testing, approval, manufacturing, commercialization and postmarking surveillance of pharmaceutical, biopharmaceutical and medical device products. This program is intended to provide students with a basic understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.



Considering the growth in the pharmaceutical industries at international level, Drug regulatory activities are being prioritized to cater to the needs of pharma global competition. India as a developing country has to look into HR expertise to address the issues related to drug laws and guidelines of regulatory agencies of various countries.

Aim and Objectives

The industry program aims to prepare aspirants for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to equip them with the educational foundation that will help them advance in the regulatory affairs profession. The course will provide the student with the fundamentals required in both regulatory affairs and quality operations. This course is designed to give industry level education in field of legal and regulatory issues. These issues are very critical to Pharma companies, Clinical Research Organization, Bio Tech companies. The course focuses on regulatory affairs concept which the Pharma companies must comply to sell their drugs both domestically and in the international market.

The course has been framed with the following objectives

• To decipher a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.
• To create experts in the field of RA documentation and research
• To help students build their career in RA and become RA professionals.
• To provide students with a global knowledge of Regulatory Affairs.

Course Modules

• Module I- Pharma Regulation Practices and Procedure
• Module II- Pharma Patents, IPR and Regulation
• Module III- Pharma Regulatory Regime in USA, EU and India
• Module IV- Clinical Trials & Regulation
• Module V- Good Manufacturing Practices, Quality Assurance and Regulation
• Module VI- Regulatory Compliance for Pharma and Biotech Products
• Research Study

Eligibility : Any Science Graduate

Program Fee

BII Program Participation Fee for this program is Rs 10,300 for participants based in India (USD 750 for overseas participants ). Payment is to be made through Demand Draft / At Par Cheque in favor of Bioinformatics Institute of India.

At the end of the duration of a program, participants go through a well defined evaluation process which is held on all India basis.

Examination Fees

Every student has to pay Rs.300/- per module as examination fees . Examination fee for overseas participants is USD 30 Per Module
Download the Examination Form

Career Opportunities

As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. The students of the program will have an understanding of the regulatory processes involved in biotechnology, medical device, pharmaceutical and food products. Students will become eligible for occupations involving drug or medical device submissions and quality assurance functions and roles. The individuals who are interested in pursuing a career in regulatory affairs would get a thorough understanding of current regulations and their application to the development and commercialization of drug, biologic and biodevice products. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes. The course would facilitate the participants with the understanding of th e areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical and medical device products.

• Pharma Regulatory Affairs Consultant
• Regulatory Officer

For further details and enquiries
Call:0120-4320801/02
Mob:09810535368,9818473366
E-mail : info@bii.in,

Global Students for any queries

E-mail : global@bii.in,
info@bii.in